New influenza vaccine offers improved protection for older adults

MHRA approves FLUAD® 1, the 1st and only adjuvanted trivalent influenza vaccine (aTIV) in the UK, specifically developed to address the burden of influenza in adults aged 65 years and over.

aTIV offers increased protection from influenza in people aged 65 years and over, compared to existing conventional non-adjuvanted influenza vaccines2

JCVI states that “published studies indicated higher vaccine immunogenicity and effectiveness for the adjuvanted vaccine in comparison with non-adjuvanted influenza vaccines”3

FLUAD is manufactured in the UK by Seqirus, the world’s 2nd largest influenza company, and can be ordered now for use in the 2018/19 influenza season

People aged 65 years and over can now be offered greater protection from influenza infection for the 2018/19 season, thanks to the UK regulator approving the adjuvanted trivalent influenza vaccine (aTIV), FLUAD®.

The Joint Committee on Vaccination and Immunisation (JCVI) - the scientific expert committee which advises the UK Government on immunisation programmes - has stated that aTIV published studies indicated “higher vaccine immunogenicity and effectiveness for the adjuvanted vaccine in comparison with non-adjuvanted vaccines”, and could “potentially be used in the [influenza] programme from the 2018/19 season”. 3

The adjuvant in FLUAD has been shown to help the body’s own immune system in recognising the inactivated virus particles contained in the vaccine, which in turn, leads to a higher immune response.4

GP and immunisation expert, Dr George Kassianos, said: “The burden of influenza in adults aged 65 years and over continues to be a significant and major problem, causing many thousands of hospitalisations and substantial excess mortality every winter.

“The gradual age-related decline of the body’s immune system, that is immunosenesence, means that older patients have a weaker response to existing conventional non-adjuvanted vaccines. The evidence shows that this new adjuvanted influenza vaccine boosts the immune response in adults aged 65 years and over, and thereby offers greater protection for this specific age group when compared to existing conventional non-adjuvanted influenza vaccines.”

Although FLUAD has only this week been launched in the UK, it already has a long track record of use in Europe and in several other countries around the world, including Canada and the US. This has meant that there is strong randomised clinical trials evidence and also real-world evidence demonstrating that FLUAD offers greater protection in people aged 65 years and over compared to existing conventional non-adjuvanted vaccines. 2

Pauline MacDonald, an Independent Consultant Nurse specialising in immunisation and former member on the JCVI, said: “This adjuvanted vaccine has a well-established safety and tolerability profile through its use in Europe and other parts of the world. Its approval in the UK offers a new effective option for healthcare professionals when making decisions about which influenza vaccines might be the most appropriate for their specific patient groups, particularly for those adults aged 65 years and older.”

FLUAD is manufactured in the UK by Seqirus, the world’s 2nd largest influenza vaccine producer. Seqirus is also the only life sciences company that dedicates its entire medical and commercial expertise to the development and manufacture of influenza vaccines.

“We understand the devastating human impact of influenza infection in adults aged 65 years and older, the substantial societal impact of influenza, as well as the cost to the NHS in preventable GP appointments and preventable hospitalisations,” said Dr Russell Basser MD, Chief Medical Officer, Seqirus.

“We believe that our strong and robust data on FLUAD’s clinical efficacy, real-world effectiveness, and well-established safety profile, built up over 20 years of use, demonstrates convincingly that this adjuvanted influenza vaccine has clear advantages for adults aged 65 years and over when compared to existing conventional non-adjuvanted vaccines. We consider that FLUAD can make a major contribution in reducing the burden of influenza on the health services, locally, regionally, and nationally.”

Seqirus, headquartered in Maidenhead, UK, was established in 2015 when the global life sciences company, CSL Limited, acquired the Novartis influenza vaccine business. CSL subsequently combined this business with its existing vaccines and pharmaceuticals subsidiary, bioCSL, to create Seqirus. The company has a rich heritage in influenza, dating right back to the Spanish Influenza Pandemic in 1918.

Seqirus operates influenza vaccine manufacturing facilities in the UK (Liverpool), the US (Holly Springs), and Australia (Melbourne), and also has research & development hubs in Boston, Amsterdam, and Melbourne. The company manufactures FLUAD at its state-of-the-art facility in Liverpool, which not only produces seasonal influenza vaccines, but also provides pandemic preparedness and response for the UK.

FLUAD can be ordered now for use in vaccination programmes for the 2018/19 influenza season.

---

Media Contact: Raine Marcus +44 7812175801.

FLUAD Safety InformationThe safety of FLUAD in elderly subjects has been assessed in 36 clinical trials in subjects ≥65 years of age, including 19 randomised controlled trials and 17 uncontrolled seasonal studies. This database includes 12,730 subjects, of which 7,532 subjects received FLUAD and 5,198 subjects received conventional non-adjuvanted trivalent influenza vaccines. In this pooled analysis, a higher percentage of subjects who received FLUAD reported both local and systemic reactions post-immunisation compared to those who received conventional non-adjuvanted TIV. Most reactions are transient, typically resolving within 1-2 days, and are mild or moderate in nature. 2

About SeqirusSeqirus is part of CSL Limited (ASX:CSL), headquartered in Melbourne, Australia. The CSL Group of companies employs more than 20,000 people with operations in more than 60 countries. Seqirus was established on 31st July 2015 following CSL’s acquisition of the Novartis influenza vaccines business and its subsequent integration with bioCSL. As the 2nd-largest influenza vaccine provider in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Seqirus operates state-of-the-art production facilities in the US, the UK, and Australia, and manufactures influenza vaccines using both egg-based and cell-based technologies. It has leading R&D capabilities, a broad portfolio of differentiated products, and a commercial presence in more than 20 countries.